Treatment was highly effective, with 98% having
continued undetectable HCV RNA at 12 weeks post-treatment (SVR12).

Glecaprevir/pibrentasvir (Maviret) is expected to be approved by the US Food and Drug
Administration in August, and it has received a positive opinion from the scientific
committee of the European Medicines Agency (the CHMP) and should receive
European Union marketing approval within the next few months.

Direct-acting antivirals (DAAs) used in
interferon-free regimens can now cure most people with all hepatitis C virus
(HCV) genotypes in 12 weeks, and easier-to-treat people – such as previously
untreated individuals with mild liver fibrosis – can usually achieve sustained
virological response (SVR) with only 8 weeks of therapy. A shorter course of treatment could
potentially improve adherence and reduce cost.

The continued, long-term suppression of a virus as a result of treatment. In hepatitis C, refers to undetectable hepatitis C RNA after treatment has come to an end. Usually SVR refers to RNA remaining undetectable for 12 or 24 weeks after ending treatment and is considered to be a cure (SVR12 or SVR24).

To eliminate a disease or a condition in an individual, or to fully restore health. A cure for HIV infection is one of the ultimate long-term goals of research today. It refers to a strategy or strategies that would eliminate HIV from a person’s body, or permanently control the virus and render it unable to cause disease. A ‘sterilising’ cure would completely eliminate the virus. A ‘functional’ cure would suppress HIV viral load, keeping it below the level of detection without the use of ART. The virus would not be eliminated from the body but would be effectively controlled and prevented from causing any illness.

The chemical structure that carries genetic instructions for protein synthesis. Although DNA is the primary genetic material of cells, RNA is the genetic material for some viruses like HIV.

People with HIV/HCV co-infection did not respond as well as HIV-negative individuals to
interferon-based therapy, and therefore this population has historically been
considered difficult to treat. However, studies in the DAA era have shown that
HIV-positive people generally do as well on interferon-free regimens as those
without HIV – though it is important to take into account the potential for
drug interactions between DAAs and antiretrovirals – and they are no longer
considered a "special population." Yet European and US HCV
treatment guidelines currently do not recommend shorter treatment for people with HIV and HCV co-infection.

Karine
Lacombe of Saint-Antoine Hospital in Paris presented findings from AbbVie's phase 3 EXPEDITION-2 trial, which evaluated
an 8-week regimen of glecaprevir/pibrentasvir for
people with both HIV and hepatitis C.

Glecaprevir is an HCV NS3/4A protease
inhibitor and pibrentasvir is an NS5A inhibitor. Both are pangenotypic, or
active against all HCV genotypes. The two drugs have been co-formulated in a
once-daily combination pill, to be marketed under the brand name Maviret.

EXPEDITION-2 enrolled 153 HIV-positive people with chronic hepatitis C in Europe, the United States and Russia.
More than 80% were men and the median age was approximately 45 years.
About two-thirds had HCV genotype 1 (mostly with harder-to-treat subtype 1a),
followed by genotypes 3 (17%) and 4 (11%); a small number had genotypes 2 or 6.

Sixteen
participants (10%) had liver cirrhosis, and most of the rest had absent or mild
fibrosis. Nearly 20% were previously treated with interferon and ribavirin, and
three had also used sofosbuvir (Sovaldi).

Study
participants had well-controlled HIV infection with a median CD4 count of
nearly 600 cells/mm3. All but nine were on antiretroviral therapy,
and about three-quarters of treated people were taking the integrase
inhibitors raltegravir (Isentress)
or dolutegravir (Tivicay), which were shown to have minimal
interactions with glecaprevir and pibrentasvir.

Participants
without cirrhosis received glecaprevir/pibrentasvir for 8 weeks,
while those with cirrhosis were treated for 12 weeks. Everyone received the study drugs
and there was no placebo arm.

Treatment was highly effective, with 98% having
continued undetectable HCV RNA at 12 weeks post-treatment (SVR12). The cure
rate rose to 99%, with no virological failures, for people without cirrhosis
who were treated for 8 weeks.

A single
patient with HCV genotype 3 and cirrhosis, who reported less than complete (85%)
adherence, experienced virological failure during treatment. Another
participant had missing data at 12 weeks post-treatment, but returned for care
at 24 weeks post-treatment and was found to be cured.

Glecaprevir/pibrentasvir was generally
safe and well tolerated. Adverse events were similar to those seen in studies of HIV-negative
people. One participant with cirrhosis stopped treatment
early due to an adverse event that was not considered drug-related (stroke and
brain haemorrhage). The most
common adverse events were fatigue, nausea, headache, and nose and throat
inflammation.

"These
results suggest that the glecaprevir/pibrentasvir regimen could be the first
8-week, pangenotypic treatment option for HCV/HIV-1 coinfected patients without
cirrhosis," the researchers concluded.

Editors’ picks from other sources

Welcome to the 2019 Pipeline Report. Our annual review provides an overview of research and development of innovations for diagnosing, preventing, treating, and curing HIV, hepatitis C virus (HCV), and tuberculosis (TB).

Welcome to the 2018 Pipeline Report, Treatment Action Group’s annual review of therapeutics, diagnostics, vaccines, and preventive technologies in development for HIV, hepatitis C virus (HCV), and tuberculosis, along with immune-based and gene therapies and research toward a cure for HIV.

Slowing hepatitis C drug sales have taken a bite out of Gilead's share price.This is a smart retreat for Merck and J&J. The HCV market is well past its peak. Both of their new therapies would have been very late; AbbVie and Gilead both had new drugs approved this year. Their best hope likely would have been to compete on price in a market that's been warring over price for a while.

The FDA recently approved two new combination regimens for hepatitis C, raising the question of whether further drug development is warranted in this area. Experts agree, however, that more remains to be done in terms of implementation: getting everyone at risk screened for HCV infection, and getting those who test positive on effective treatment.

Janssen Sciences Ireland UC, a unit of Johnson & Johnson, said it would discontinue further development of its hepatitis C research, citing increased availability of a number of effective hepatitis C therapies.

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